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Lurasidone Extended Use Study

Primary Purpose

Schizophrenia, Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lurasidone
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, bipolar disorder, Lurasidone, Latuda

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required.
  • The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study.
  • The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol.
  • The subject, in the Investigator's judgment, may benefit from continued treatment with lurasidone

Exclusion Criteria:

  • The subject is considered by the Investigator, to be at imminent risk for homicidal or suicidal behavior.
  • The subject resides in a country where lurasidone has been approved for any indication.
  • The subject is currently enrolled in any other investigational study.
  • The subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).

Sites / Locations

  • Okanagan Clinical Trials
  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations
  • E.S.E. Hospital Mental de Antioquia
  • CISNE - UIC Campo Abierto
  • Psychiatricka ambulance
  • Vojenska nemocnice Olomouc
  • Clintrial, s.r.o.
  • Psychiatry Trial s.r.o.
  • Medical Services Prague s.r.o.
  • Zans Ritter, Marcel
  • Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)
  • Brain Mind Behavior Neuroscience Research Institute
  • Vijayawada Institute of Mental Health and Neurosciences
  • Samvedna Hospitals
  • Seth K M School of P G Medicine & Research
  • Mental Health Treatment Rehabililitation Foundation Dept. of Psychiatry
  • Hatkesh Healthcare Foundation
  • Brij Psychiatry Hospital & Muskaan Research Centre
  • Shanti Nursing Home
  • Dr. Tambi's Neuropsychiatry Center
  • R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry
  • Mahendru Psychiatric Centre
  • Neuromeda JSC
  • JSC Neuromeda
  • Seskines Outpatient Clinic, Public Institution
  • Spitalul Clinic Judetean de Urgenta Cluj
  • Spitalul Clinic de Neuropsihiatrie Craiova
  • Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'
  • St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1
  • St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)
  • St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"
  • Institute of Mental Health
  • Clinical Centre Nis, Clinic for mental health protection
  • Psychiatricka ambulancia Mentum s.r.o.
  • PsychoLine s.r.o. Psychiatricka ambulancia
  • Centrum zdravia R.B.K. s.r.o. Psychiatricka ambulancia
  • Pro mente sana s.r.o. Psychiaricka ambulancia
  • Dey Clinic
  • Cape Trial Centre
  • Denmar Hospital Consulting Rooms
  • Kherson Regional Psychiatric Hospital
  • Dnipropetrovsk Regional Clinical Hospital named Mechnikov
  • Regional Clinical Psychiatric Hospital, Dept #11
  • Institute of Neurology, Psychiatry and Narcology, NAMS of Ukraine
  • Crimean republican Clinical Psychiatric Hospital
  • Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lurasidone

Arm Description

Lurasidone flexibly dosed

Outcomes

Primary Outcome Measures

Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs
Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.

Secondary Outcome Measures

Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S
The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.

Full Information

First Posted
December 1, 2011
Last Updated
September 29, 2016
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01485640
Brief Title
Lurasidone Extended Use Study
Official Title
A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder
Keywords
Schizophrenia, bipolar disorder, Lurasidone, Latuda

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lurasidone
Arm Type
Experimental
Arm Description
Lurasidone flexibly dosed
Intervention Type
Drug
Intervention Name(s)
Lurasidone
Intervention Description
Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Primary Outcome Measure Information:
Title
Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs
Description
Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S
Description
The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
Time Frame
18 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required. The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study. The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol. The subject, in the Investigator's judgment, may benefit from continued treatment with lurasidone Exclusion Criteria: The subject is considered by the Investigator, to be at imminent risk for homicidal or suicidal behavior. The subject resides in a country where lurasidone has been approved for any indication. The subject is currently enrolled in any other investigational study. The subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, MD
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Okanagan Clinical Trials
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations
City
Barranquilla
Country
Colombia
Facility Name
E.S.E. Hospital Mental de Antioquia
City
Bello
Country
Colombia
Facility Name
CISNE - UIC Campo Abierto
City
Bogota
Country
Colombia
Facility Name
Psychiatricka ambulance
City
Brno-mesto
ZIP/Postal Code
602 00
Country
Czech Republic
Facility Name
Vojenska nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
711 11
Country
Czech Republic
Facility Name
Clintrial, s.r.o.
City
Praha
ZIP/Postal Code
10 100 00
Country
Czech Republic
Facility Name
Psychiatry Trial s.r.o.
City
Praha
ZIP/Postal Code
158 00
Country
Czech Republic
Facility Name
Medical Services Prague s.r.o.
City
Praha
ZIP/Postal Code
6 160 00
Country
Czech Republic
Facility Name
Zans Ritter, Marcel
City
Orvault
ZIP/Postal Code
44700
Country
France
Facility Name
Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)
City
Toulun
ZIP/Postal Code
83000
Country
France
Facility Name
Brain Mind Behavior Neuroscience Research Institute
City
Vishakhapatnam
State/Province
Andh Prad
ZIP/Postal Code
530002
Country
India
Facility Name
Vijayawada Institute of Mental Health and Neurosciences
City
Vijayawada
State/Province
Andhra Pradesh
ZIP/Postal Code
520002
Country
India
Facility Name
Samvedna Hospitals
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Seth K M School of P G Medicine & Research
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Mental Health Treatment Rehabililitation Foundation Dept. of Psychiatry
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380013
Country
India
Facility Name
Hatkesh Healthcare Foundation
City
Junagadh
State/Province
Gujarat
ZIP/Postal Code
362001
Country
India
Facility Name
Brij Psychiatry Hospital & Muskaan Research Centre
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390001
Country
India
Facility Name
Shanti Nursing Home
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431005
Country
India
Facility Name
Dr. Tambi's Neuropsychiatry Center
City
Jaipur
State/Province
Rajaasthan
ZIP/Postal Code
302017
Country
India
Facility Name
R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302021
Country
India
Facility Name
Mahendru Psychiatric Centre
City
Kanpur
ZIP/Postal Code
208005
Country
India
Facility Name
Neuromeda JSC
City
Kaunas
ZIP/Postal Code
50185
Country
Lithuania
Facility Name
JSC Neuromeda
City
Kaunas
ZIP/Postal Code
LT-50185
Country
Lithuania
Facility Name
Seskines Outpatient Clinic, Public Institution
City
Vilnius
ZIP/Postal Code
07156
Country
Lithuania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj
City
Cluj-Napoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
Spitalul Clinic de Neuropsihiatrie Craiova
City
Craiova
ZIP/Postal Code
200620
Country
Romania
Facility Name
Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'
City
Lipetsk
ZIP/Postal Code
398007
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1
City
St. Petersburg
ZIP/Postal Code
19005
Country
Russian Federation
Facility Name
St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"
City
St. Petersburg
ZIP/Postal Code
191167
Country
Russian Federation
Facility Name
Institute of Mental Health
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Centre Nis, Clinic for mental health protection
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Psychiatricka ambulancia Mentum s.r.o.
City
Bratislava
ZIP/Postal Code
82007
Country
Slovakia
Facility Name
PsychoLine s.r.o. Psychiatricka ambulancia
City
Rimavska Sobota
ZIP/Postal Code
97901
Country
Slovakia
Facility Name
Centrum zdravia R.B.K. s.r.o. Psychiatricka ambulancia
City
Svidnik
ZIP/Postal Code
08901
Country
Slovakia
Facility Name
Pro mente sana s.r.o. Psychiaricka ambulancia
City
Trencin
ZIP/Postal Code
91101
Country
Slovakia
Facility Name
Dey Clinic
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
181
Country
South Africa
Facility Name
Cape Trial Centre
City
Tygervalley
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Denmar Hospital Consulting Rooms
City
Pretoria
ZIP/Postal Code
0081
Country
South Africa
Facility Name
Kherson Regional Psychiatric Hospital
City
Kherson
State/Province
Vil Stepanivka
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Regional Clinical Psychiatric Hospital, Dept #11
City
Donetsk
ZIP/Postal Code
83037
Country
Ukraine
Facility Name
Institute of Neurology, Psychiatry and Narcology, NAMS of Ukraine
City
Khardov
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Crimean republican Clinical Psychiatric Hospital
City
Simferopol
Country
Ukraine
Facility Name
Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21
City
Vinnitsia
ZIP/Postal Code
21018
Country
Ukraine

12. IPD Sharing Statement

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Lurasidone Extended Use Study

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